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ENHERTU Powder for concentrate for solution for infusion (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Enhertu 100 mg powder for concentrate for solution for infusion.

2. Qualitative and quantitative composition

One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab deruxtecan. After reconstitution, one vial of 5 mL solution contains 20 mg/mL of trastuzumab deruxtecan (see ...

3. Pharmaceutical form

Powder for concentrate for solution for infusion. White to yellowish-white lyophilised powder.

4.1. Therapeutic indications

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

4.2. Posology and method of administration

Enhertu should be prescribed by a physician and administered under the supervision of a healthcare professional experienced in the use of anticancer medicinal products. In order to prevent medicinal product ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

In order to prevent medicinal product errors, it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Enhertu (trastuzumab deruxtecan) and not trastuzumab ...

4.5. Interaction with other medicinal products and other forms of interaction

Co-administration with ritonavir, an inhibitor of OATP1B, CYP3A and P-gp, or with itraconazole, a strong inhibitor of CYP3A and P-gp, resulted in no clinically meaningful (approximately 10-20%) increase ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females Pregnancy status of women of childbearing potential should be verified prior to initiation of Enhertu. Women of childbearing potential ...

4.7. Effects on ability to drive and use machines

Enhertu may have a minor influence on the ability to drive and use machines. Patients should be advised to use caution when driving or operating machinery in case they experience fatigue, headache or dizziness ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions were nausea (79.9%), fatigue (60.3%), vomiting (48.7%), alopecia (46.2%), constipation (35.9%), decreased appetite (34.6%), anaemia (33.8%), ...

4.9. Overdose

The maximum tolerated dose of trastuzumab deruxtecan has not been determined. In clinical studies, single doses higher than 8.0 mg/kg have not been tested. In case of overdose, patients must be closely ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antineoplastic agents, HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors <b>ATC code:</b> L01FD04 Mechanism of action Enhertu, trastuzumab deruxtecan, is a HER2-targeted ...

5.2. Pharmacokinetic properties

Absorption Trastuzumab deruxtecan is administered intravenously. There have been no studies performed with other routes of administration. Distribution Based on population pharmacokinetic analysis, the ...

5.3. Preclinical safety data

In animals, toxicities were observed in lymphatic and haematopoietic organs, intestines, kidneys, lungs, testes and skin following the administration of trastuzumab deruxtecan at exposure levels of the ...

6.1. List of excipients

L-histidine L-histidine hydrochloride monohydrate Sucrose Polysorbate 80

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Sodium chloride solution for infusion must not be ...

6.3. Shelf life

<u>Unopened vial:</u> 3 years. <u>Reconstituted solution:</u> Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2ºC to 8ºC. From a microbiological point of view, the product ...

6.4. Special precautions for storage

Store in a refrigerator (2ºC-8ºC). Do not freeze. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

Enhertu is provided in 10 mL Type 1 amber borosilicate glass vial sealed with a fluoro-resin laminated butyl rubber stopper, and a polypropylene/aluminium yellow flip-off crimp cap. Each carton contains ...

6.6. Special precautions for disposal and other handling

In order to prevent medicinal product errors, it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Enhertu (trastuzumab deruxtecan) and not trastuzumab ...

7. Marketing authorization holder

Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany

8. Marketing authorization number(s)

EU/1/20/1508/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 18 January 2021 Date of latest renewal: 12 November 2021

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